UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022774 |
|---|---|
| Receipt number | R000026191 |
| Scientific Title | Relationship between morphological and mechanical characteristics of human soft tissues and physical functions - a study for the effect of exercise and dietary supplements on human skeletal muscle properties. |
| Date of disclosure of the study information | 2017/06/15 |
| Last modified on | 2016/06/14 17:48:02 |
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Basic information
Public title
Relationship between morphological and mechanical characteristics of human soft tissues and physical functions - a study for the effect of exercise and dietary supplements on human skeletal muscle properties.
Acronym
A study for the effect of exercise and dietary supplements on human skeletal muscle properties.
Scientific Title
Relationship between morphological and mechanical characteristics of human soft tissues and physical functions - a study for the effect of exercise and dietary supplements on human skeletal muscle properties.
Scientific Title:Acronym
A study for the effect of exercise and dietary supplements on human skeletal muscle properties.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of exercise and dietary supplements on morphological and mechanical characteristics of human soft tissues and physical functions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Thickness of skeletal muscles
Key secondary outcomes
-Body height, mass and composition
-Skeletal muscle mass
-Muscle strength
-Subcutaneous adipose tissue thickness at the thigh
-3D body shape measurement
-Dietary intake
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Intake of the test dietary supplements for 3 months.
Interventions/Control_2
Intake of the placebo supplements and exercise for 3 months.
Interventions/Control_3
Intake of the test dietary supplements and exercise for 3 months.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 25 | years-old | <= |
Age-upper limit
| 39 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy women with no regular exercise habit.
Key exclusion criteria
-Persons currently suffering from diseases.
-Persons with food allergies.
-Persons pparticipating in other tests.
-Persons suffering from pain due to bone fracture, muscle sprain or strain injuries.
-Persons who are or may be pregnant.
-Persons who are breastfeeding.
-Persons with claustrophobia.
-Persons with implanted metallic materials (pacemakers, artificial joints etc.).
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuo Kawakami |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
Address
2-579-15 Mikajima, Tokorozawa city, Saitama
TEL
04-2947-6784
ykawa@waseda.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuo Kawakami |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
Address
2-579-15 Mikajima, Tokorozawa city, Saitama
TEL
04-2947-6784
Homepage URL
ykawa@waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Shiseido Co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
早稲田大学所沢キャンパス（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2016 | Year | 06 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 17 | Day |
Last modified on
| 2016 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026191
